Kornimate/medical-research-clean huggingface dataset:
flow sensor and colourimetric capnometer in verifying tracheal tube positioning in term and preterm infants

Conditions: Tracheal Intubation

Summary: this is a multicentre clinical trial with medical device. as currently recommended by international neonatal resuscitation guidelines, the most reliable method to verify the correct positioning of the endotracheal tube, in association with clinical signs, is the end-tidal capnometry obtained either by infrared spectroscopy or colorimetric method. the aim of the present study is to evaluate whether the flow sensor of a standard mechanical ventilator can discriminate with similar or faster times the correct positioning of the tube after a tracheal intubation attempt compared to the colorimetric capnometer, in newborns undergoing this procedure during hospitalization in the neonatal intensive care unit. given the importance of defining a rapid and effective method to prevent possible adverse events of incorrect endotracheal intubation, this study aims to verify whether the ventilator flow sensor can allow a reliable assessment of the correct positioning of the endotracheal tube, with timing and success rates equivalent to or better than the colorimetric capnometer.

specifically, the neonatologist performing the procedure will follow the standard procedure for tracheal intubation, which includes using a colourimetric capnometer to confirm the correct tube positioning. however, he/she will remain blind and not aware of the flow sensor signal, while a study investigator will monitor that. the investigators will measure the percentage of responses of correct positioning of the endotracheal tube as well as the number of insufflations and the time elapsed before obtaining a signal of correct intubation by simultaneously comparing both methods and checking any differences based on the characteristics of the sample analyzed (e.g. premature infants versus term infants, elective versus emergency intubations).

Eligibility criteria:
inclusion criteria: term and preterm infants requiring tracheal intubation within the neonatal intensive care unit, both in elective and emergency conditions. exclusion criteria: * intubation at birth * intubation during cardiopulmonary resuscitation * absence of informed consent by parents

Keywords: tracheal intubation tracheal tube positioning colorimetric capnometer flow sensor invasive mechanical ventilation newborn preterm infant
durable-i study: dielectric unravelling of radiofrequency ablation effectiveness

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to evaluate real-time gap detection using epd d700 dielectric sensing compared with customary electrical isolation tests and adenosine infusion at the end of the procedure. furthermore, safety, usability and clinical applicability of the system for guided af ablation will be confirmed.

prospective, single-center, non-randomized, non-blinded, open label, and single arm study. all procedures will be performed under carto-3 guidance for the treatment of atrial fibrillation (af). the epd d700 system will be used in-tandem, to record pre-, during and immediate post-ablation tissue characteristics and compute likelihood of lesion transmurality and permanency. additionally, d700 system safety, feasibility, usability and clinical applicability will be documented. the entire procedure will be conducted as customary, using standard and approved off-the-shelf equipment (body surface electrodes, diagnostic and irrigated ablation catheters, rf generator and recording system), in a completely clinically independent manner from the epd d700 system. the physician will neither use nor rely on any of the d700 system output for clinical decision making and will be blinded to the d700 lesion assessment forecasts. after 30 days following the initial procedure, a repeated procedure will be performed for gap detection and its results will be correlated with the d700 predictions.

Eligibility criteria:
inclusion criteria: 1. male or female patients, age ≥ 18 and ≤ 80 years. 2. paroxysmal atrial fibrillation (paf) 3. able to provide written informed consent form to participate in the study, prior to any study related procedures. 4. able and willing to comply with the study protocol requirements. 5. a female subject is eligible if not of child bearing potential or has a negative pregnancy test within the previous 7 days. exclusion criteria: 1. any planned surgical or endovascular intervention within 30 days before or after the index procedures. 2. subject is enrolled in another drug or device study protocol that has not reached its primary endpoint. 3. previous af ablation therapy. 4. clinical evidence of active coronary ischemia, significant valvular heart disease, or hemodynamically significant congenital cardiac abnormality. 5. patient had experienced myocardial infarction (mi), stroke (cva) or transient ischemic attack (tia) or other neurological disturbances. 6. patient has a pacemaker. 7. thrombi detected in the heart. 8. life expectancy less than 12 months. 9. known severe renal insufficiency. 10. known allergy to iodine.
a trial of pyridoxamine to lower urine oxalate in subjects with stone disease or hyperoxaluria

Conditions: Kidney Stones

Summary: to determine whether pyridoxamine can decrease oxalate excretion in subjects who have normal oxalate excretion (but who have had kidney stones), and in subjects who have primary hyperoxaluria.


Eligibility criteria:
inclusion criteria: * adults \> 18 years * history of stone formation * good renal function * normal urinary excretion of stone-promoting chemicals(ca, uric acid, oxalate, citrate), except for subjects with hyperoxaluria for study exclusion criteria: * pregnancy * hyperparathyroidism * enteric hyperoxaluria. * obstructive uropathy * infection (struvite) stones * severe dietary ca++ restriction or deficiency * recent significant cardio-vascular events
acute effects of three different types single leg exercise in copd

Conditions: Exercise

Summary: copd presents not only respiratory symtoms but also vascular or muscle dysfunction. exercise training is important for aerobic performance increasing. generally results show exercise training with both lower limb. increaed arterial stiffness and muscle oxygenation are observed in copd. one leg exercise result is not enough to highlight these parameters.

acute effects of three different types single leg exercise in copd single bout high intensity interval training single bout continuous exercise training single bout resistance training

Eligibility criteria:
inclusion criteria: * copd patients that applied to physiotherapy * cooperate to test * no severe ortopedical and neurological disease no severe cardiovascular disease volunteer to study exclusion criteria: * have an acute exacerbation * hypoxemia \[pao2\] \<55 mmhg * no cooperated to test no volunteer to study having ortophedical and neurological diesase that affecting of tests having severe cardiovascular disease
effects of monitoring blood pressure during pregnancy

Conditions: Birth Weight; Weight Gain Trajectory

Summary: in this study, at least 400 women with high-risk of pregnancy hypertension will use a wearable device to monitor the blood pressure during gestational age from 12 weeks to 28weeks. the observed outcomes including maternal and offspring. participants were from three hospital including shanghai xinhua hospital, jiaxing maternal and child health hospital and peking university third hospital. pregnant women were randomly divided into control group (routine delivery examination group) and intervention group (routine delivery examination group + use of wearable blood pressure monitoring device group), 200 cases each.


Eligibility criteria:
inclusion criteria: * women with a single pregnancy before 12 weeks of pregnancy * the presence of any of the following risk factors: age \> 30 years, a history of eclampsia, a family history of eclampsia, obesity (bmi ≥ 30 kg/m2), and a history of gestational hyperglycemia (pregestational type 1 and type 2 diabetes; gestational manifest diabetes and gestational diabetes requiring insulin treatment), preexisting chronic hypertension, kidney disease, and autoimmune diseases such as systemic lupus erythematosus and antiphospholipid syndrome. * signed the informed consent can be continuously followed up. * permanent population living in the study area. * all subjects received routine antenatal examination and treatment. exclusion criteria: * termination of pregnancy before 20 weeks * withdraw from the study * lost visitors
long-term evaluation of the quality of life of former patients treated with orthopedic surgery, with or without radiotherapy

Conditions: Osteosarcoma in Children

Summary: surgery and radiation therapy play a major role in the treatment of bone and soft tissue tumors. osteosarcomas, rhabdomyosarcomas, and ewing tumors are the most common histologic types. surgery may require multiple techniques and radiation therapy may be conformational, or more recently imrt (intensity modulated radiation therapy). if surgery is possible, lower limb surgery is generally the recommended treatment, even if a poor functional result can be expected. the literature is very poor regarding the impact of radiotherapy on quality of life and functional results, mainly with the use of prosthetic materials. tools such as the toronto extremity salvage score (tess) are now available for self-assessment of functional outcomes. the presence of large cohorts such as fccss, cohoper and salto facilitates these studies. the sf-36 is a short 36-question health questionnaire that consists of a generic, consistent, and easy-to-administer set of measures. these measures are based on self-report by patients and are now widely used by organizations managing the care of adult patients. the tess functional questionnaire is a patient-completed self-questionnaire widely used for motor stimulation in patients with musculoskeletal tumors. this score is based on the definitions of handicap, impairment and handicap as documented by the world health organization (who). it includes 30 questions assessing overall function and daily activities. the final score varies from 0% to 100%, 100% being the best possible score. so far, several studies have reported the validation of tess in portuguese, danish, korean, japanese and since this year in french. indeed, the tess questionnaire was validated in french by the study "transcultural validation of tess and msts questionnaires" promoted by the nantes university hospital.


Eligibility criteria:
inclusion criteria: patients from the french fccss or cohoper or salto cohorts adult patient (\> 18 years old) when filling out the study questionnaires patient treated for a bone tumor before the age of 18 patient with a minimum follow-up of 5 years without cancer treatment (treated before 2014) patient living in france and speaking french exclusion criteria: patient with a 2nd cancer patient who has already been approached by the hospital de nantes as part of the cross-cultural validation of the tess questionnaire

Keywords: quality of life long term follow up orthopedic surgery radiotherapy
west virginia wisewoman pilot study to test a brief nutrition intervention

Conditions: Heart Disease; Blood Pressure; Obesity

Summary: to provide low-income, under- or uninsured 40- to 64-year-old women with the knowledge, skills, and opportunities to improve diet, physical activity, and other lifestyle behaviors to prevent, delay and control cardiovascular and other chronic diseases.

to test whether a brief, interactive, computer-based nutrition intervention (cookin' up health)impacts various health outcomes

Eligibility criteria:
inclusion criteria: * nbccedp * aged 40-64 * attends selected rural clinics exclusion criteria: -
characterization of non-steroidal anti-inflammatory drug (nsaid) intake in rheumatoid arthritis (ra) participants on tocilizumab (roactemra®) treatment

Conditions: Rheumatoid Arthritis

Summary: this nationwide, multicenter, single arm, prospective, non-interventional study will evaluate the quantitative pattern of nsaid use and the impact of treatment with tocilizumab on nsaid use in a representative cohort of participant with moderate to severe active ra who have either responded inadequately to, or who were intolerant to previous therapy with one or more synthetic disease modifying anti-rheumatic drug (sdmard), and for whom the physician has made the individual decision to initiate tocilizumab (subcutaneous \[sc\] or intravenous \[iv\]) as first biological disease modifying anti-rheumatic drug (dmard) therapy according to the summary of product characteristics (spc).


Eligibility criteria:
inclusion criteria: * participants with moderate to severe active ra who have either responded inadequately to, or who were intolerant to, previous therapy with one or more sdmards and for whom the physician has made the individual decision to be treated with tocilizumab (sc or iv) * current users of nsaids due to ra as assessed by the physician exclusion criteria: * contraindications to treatment with tocilizumab as per spc * prior therapy with tocilizumab
framingham nutrition studies

Conditions: Cardiovascular Diseases; Heart Diseases; Coronary Disease; Hypertension

Summary: to examine hypotheses concerning the relationships between nutrient intake (in particular, specific fatty acids, antioxidant nutrients, and b vitamins), dietary patterns, plasma lipoproteins, and heart disease endpoints in the population-based framingham offspring studies.

design narrative: longitudinal analyses were conducted on the associations between diet and cardiovascular and cardiopulmonary disease risk in approximately 3,800 offspring men and women over eight years of follow-up (from 1984 to present). these analyses considered key nutrients as well as newly defined dietary patterns in framingham men and women. cross sectional analyses of diet and plasma lipoprotein relationships in offspring men and women at two examinations (exam 3, 1984-88; and exam 5, 1991-94) were also conducted. all analyses evaluated the total (direct and indirect) and joint effects of dietary nutrients. where appropriate, analyses controlled for plasma nutrient levels (folacin, vitamins b6 and b12 and homocysteine). the influence of potential confounding variables, effect modifiers, and intervening variables that lie in the causal pathway were examined, as appropriate to the statistical model, including traditional cardiovascular disease risk factors and apoe isoform status. several existing framingham data sets were utilized, including comprehensive data sets on nutrient intake, cardiovascular disease risk factors, clinically verified cardiovascular and cardiopulmonary endpoints and other covariates. the offspring exam 3 and 5 nutrition data sets included multiple day assessments of dietary intake which improved the ability to detect relationships of interest. the investigators completed the framingham food habit questionnaire data set for exam 5; this instrument included important covariates for the analyses (including vitamin supplement use). the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
the counter-irritating efficacy of topical povidone-iodine in thermal burns

Conditions: Skin Burns

Summary: skin burns are one of the causes of disability, suffering and death in humans. anecdotal, uncontrolled studies have shown the efficacy of povidone-iodine ointment in human skin burns, provided the preparation was applied shortly after the exposure to the heat source. the proposed study will conduct a controlled study in which the effect of povidone-iodine ointment will be tested in large group of patients and will be compared with standard cold water treatment.

skin burns are one of the causes of disability, suffering and death in humans. the current treatment includes application of cold water or other plant origin preparations. however non of these treatments was shown to be efficacious. animal studies have demonstrated the pronounced protective effect of povidone-iodine ointment against thermal burns. moreover, anecdotal, uncontrolled studies in humans have shown the efficacy of povidone-iodine ointment in human skin burns, provided the preparation was applied shortly after the exposure to the heat source. the proposed study will conduct a controlled study in which the effect of povidone-iodine ointment will be tested in large group of patients and will be compared with standard cold water treatment.

Eligibility criteria:
inclusion criteria: * skin burns in children exclusion criteria: * allergy to iodine

Keywords: skin burn povidone iodine cold water
catechin gargling for influenza infection

Conditions: Influenza Infection

Summary: the purpose of this study is to clarify the preventive effects of catechin gargling on the influenza infection.

in-vitro experimental studies have revealed that tea catechin extracts induce preventive effects on influenza infection. however, few studies have been conducted on the effects of tea gargling on influenza infection, and the clinical evidence is unclear. also there have been no studies reported on the gargling effects with tea catechin extracts on the prevention of influenza infection.

Eligibility criteria:
inclusion criteria: * healthy volunteers * aged 20 to 65 years old * obtained written informed concent before participation * inoculated with influenza vaccine before entering the study exclusion criteria: * other gargling except water during the study * possessing tea allergy

Keywords: catechins gargling healthy volunteers
pretreatment to reduce pain and discomfort during fiberoptic nasal pharyngoscopy and laryngoscopy

Conditions: Throat Disorder

Summary: fiberoptic laryngoscopy (fol) is one of the most common procedure done in an ear nose throat (ent) clinic. topical anesthesia or decongestant or both have been used to improve patient comfort level during the procedure. recently, role of these agents has been questioned. the investigators would like to study whether topical anesthesia or decongestant or their combination provide any benefit to the patients undergoing fol.

patient undergoing fiberoptic laryngoscopy (fol) will be randomized into four groups by block randomization. group one will receive atomized spray of normal saline as placebo before the procedure. group two will receive two sprays of atomized oxymetazoline (approx 0.18 ml of 0.05% oxymetazoline) with a gap of 10 seconds in between the sprays. group three will receive two sprays of 15% lidocaine with a gap of 10 seconds in between the sprays. group four will receive two sprays of oxymetazoline and then two sprays of lidocaine at an interval of two minutes. sample size calculation: with alpha error of 0.05, power of .8, mean discomfort scale for placebo of 2.8 (literature review) and sd of 1.1, presuming that the treatment would be able to reduce discomfort by at least 25%, with two tailed test and same sd, minimum sample size would be 40 in each group. to reduce bias, all the procedure will be performed by senior consultants. patients and the person performing the procedure will be blinded. discomfort of pre-medication, discomfort of scope insertion, pain due to scope insertion, and ease of procedure will be scored as vas score (1 to 10, 1 is least and 10 is most). also, patient will be asked how likely s/he is to recommend the similar procedure to his/her friends and family members in case they need to undergo the same. side effects of pre-medication and procedure will also be noted. outcome variables among the groups will be compared using anova test if they are normally distributed.

Eligibility criteria:
inclusion criteria: * patients undergoing fiberoptic naso pharyngo laryngoscopy in opd setting * consent to study * above 18 years exclusion criteria: * gross nasal mass * pregnants * known hypersensitivity to the drugs used for premedication * who cannot respond to questionnaire during data collection
high flow versus niv for acute cardiogenic pulmonary oedema with acute respiratory failure in an ed

Conditions: Cardiogenic Pulmonary Edema

Summary: the purpose of this study is to compare non invasive ventilation to high flow nasal cannula oxygen for the management of patients admitted with an acute respiratory failure due to an acute cardiogenic pulmonary edema.

acute cardiogenic pulmonary oedema is a leading cause of acute respiratory distress in patients admitted in an emergency department. with diuretics and nitrite derivative, noninvasive ventilation is the first-line treatment of acute pulmonary oedema recommended by the european society of cardiology. noninvasive ventilation is able to reduce the respiratory rate faster than standard oxygen therapy, to improve oxygenation, and some data suggest it could reduce the mortality rate. niv may be poorly tolerated in certain patients, in whom it is associated with failure of treatment and poor outcomes. high-flow nasal cannula heated and humidified oxygen (hfno) is a ventilatory support used in icu and recently introduced in emergency departments. as compared niv and standard oxygen therapy, hfno reduces the mortality rate in patients with acute hypoxemic respiratory failure hospitalized in an icu. in addition, in these patients, hfno is also better tolerated than noninvasive ventilation. some data suggested hfno is superior to standard oxygen therapy in acute pulmonary oedema and could have a similar clinical effect to niv. however, there is no research that has compared tolerance of patients admitted in an ed with acute pulmonary oedema and treated by hfno or niv. included patients will be treated with niv or hfno. niv will be provided with an emergency and transport ventilator (monnal t60, airliquide, antony, france) and hfno will be provided with an airvo2 device (fisher and paykel, new zealand). patients will be treated in an emergency department immediately after their admission and their consent. treatment will be provided for a minimum of one hour. tolerance of patients will be measured under treatment using a comfort numerical scale from 0 - well comfortable to 10 extremely uncomfortable. clinical and biological patterns will be also recorded. patients will be followed from their inclusion to 28 days after their inclusion.

Eligibility criteria:
inclusion criteria: * age over or equal 18 years old * admitted in an emergency department * acute respiratory failure defined by a respiratory rate over or equal 25 breathes/min or signs of increased work of breathing * clinical suspicion of acute heart failure defined bu the european cardiologic society. exclusion criteria: * patient requiring immediate invasive mechanical ventilation * neurologic distress defined by a glasgow coma scale under 13 * haemodynamic failure defined by a mean blood pressure under 65 mmhg or patient requiring catecholamines